The Food and Drug Administration has posted a request for public comment on possible changes to the FDA’s current policy barring gay men from donating blood unless they have been sexually abstinent for a full year. According to the notice, the FDA appears ready to consider changing that policy (PDF: 321KB/7 pages):

Interested persons are invited to submit comments, supported by scientific evidence such as data from research, regarding potential blood donor deferral policy options to reduce the risk of HIV transmission, including the feasibility of moving from the existing time-based deferrals related to risk behaviors to alternate deferral options, such as the use of individual risk assessments. Additionally, comments are invited regarding the design of potential studies to evaluate the feasibility and effectiveness of such alternative deferral options. FDA will take the comments received into account as it continues to reevaluate and update blood donor deferral policies as new scientific information becomes available.

Before last December, it had been FDA policy to permanently ban all men who had ever had sex with another man. That policy was updated to limit that ban to men who had sex with other men in the last twelve months, which, it said, was “better align[ed] the deferral period for MSM with the deferral period for other men and women at increased risk for HIV infection, such as those who had a recent blood transfusion or who have been accidentally exposed to the blood of another individual through a needle stick.”

According to this latest request for comment, the FDA is now considering proposals that would “move from a time- based deferral period to a deferral policy based on individual risk assessment. An individual risk assessment would involve asking potential donors a series of questions designed to defer donors with high risk behaviors.” The request sought comment on what kinds of questions to ask, how specific should they be and still be “understandable and acceptable to all blood donors” while also ensuring donors will answer them accurately, and what other procedural changes might be necessary to ensure the risk assessments are being performed. The notice also requests input for the design of a potential study “to evaluate the feasibility and effectiveness of alternative deferral options such as individual risk assessment.”

There’s an arbitrary FDA ban on blood donations for gay men who have had sex in the past year. It appears that the ban has been lifted, at least temporarily in Orlando. U.S. Representative Alan Grayson (D-FL) released this statement at 12:30 am EST Sunday:

“Due to the critical need for blood donations in Orlando, ALL blood donations will be accepted and screened. Nobody will be turned away because of their sexual orientation. O Positive and O Negative blood types are needed most urgently. Please make appointments to donate throughout the week as there will be a continued need.”

HIV Plus magazine noticed earlier that local hospitals appear to be accepting blood from all comers.

Update: Others are suggesting that the blood banks are accepting donations, but are probably using the application forms to screen out those who answer the gay-and-had-sex question to dispose of that donation.

The need for blood after a shooting at a gay nightclub resurfaced complaints on social media about limits on gay men’s ability to donate blood. In December, the Food and Drug Administration lifted a lifetime ban for gay men, but continued to prohibit men from donating if they had had sex with men in the past year.

Since 1983 the Food and Drug Administration has forbidden any man who had ever had sex with another man – even once – since 1977 from donating blood, out of fear of transmitting the Human Immunodeficiency Virus. And while that made sense in 1983, for many years that has been a policy based on fear and stereotype instead of science.

All blood donated is tested for bloodborne pathogens, including HIV. And current tests allow detection of an HIV infection as recently as nine days after exposure.

Considering that men who have sex with men continue to account for over half of all new HIV infections, it does not seem unreasonable for there to be some waiting period after a sexual encounter for a gay man to donate blood in many instances, just to be certain that he hasn’t been infected too recently to have tests identify the virus.

But forty-seven years is an excessive amount of time to wait.

Several other nations – including the United Kingdom, Australia, New Zealand, Finland, and Japan – have all revised their restrictions to a much smaller abstinence window, most selecting one year. Now the United States has followed suit. (Washington Post)

The Food and Drug Administration on Monday lifted a decades-old, lifetime ban on blood donation for men who have had sex with other men, replacing it with a 12-month “deferral” period that prohibits such donors from giving blood for a year after their last same-sex contact.

The agency said its updated policy reflects “the most current scientific evidence” and mirrors the approach taken in other countries, such as Australia and the United Kingdom. “We have taken great care to ensure this policy revision is backed by sound science and continues to protect our blood supply,” FDA Acting Commissioner Stephen Ostroff said in a statement.

I don’t agree that this reflects “the most current scientific evidence”. It seems to me that a much shorter window – maybe a few weeks or a month – could be utilized with the same level of protection. It also seems to me that a person on PrEP would present no risk to the blood supply irrespective of their most recent sexual experience. As would those in monogamous relationships in which neither party is HIV+.

But this is a step in the right direction. And the FDA has said that it is a “first step” and is likely to evolve. Let’s hope the next step reflects individual risk assessment. Let’s also hope that it comes a bit sooner than 23 years.

Many other industrial leading nations now have lifted their lifetime ban on blood donations by gay men. Now the American Medical Association has called on the US Food and Drug Administration to do the same. (ABC)

The American Medical Association voted Tuesday to oppose a decades long ban by the U.S. Food and Drug Administration, which prohibits gay men from donating blood.
…
“The lifetime ban on blood donation for men who have sex with men is discriminatory and not based on sound science,” AMA board member Dr. William Kobler said in a statement. “This new policy urges a federal policy change to ensure blood donation bans or deferrals are applied to donors according to their individual level of risk and are not based on sexual orientation alone.”

As in the United States and much of the world, in the 1980’s the United Kingdom implemented a ban on blood donations by gay men. The UK Department of Health has now revised the ban to reflect the changes in blood analysis and knowledge about HIV that have occurred since that time. (herald)

.. following a review by the Advisory Committee on the Safety of Blood, Tissues and Organs (Sabto), men who have not had homosexual sex within a year will be able to donate if they meet certain other criteria. The move will be implemented in England, Scotland and Wales.

Men who have had anal or oral sex with another man in the past 12 months, with or without a condom, will still not be eligible to donate blood, the DoH said. They said this was to reduce the risk of infections being missed by testing and then being passed on to a patient.

Health officials agree that this policy change will not measurably increase risk of HIV contaminated blood.

However, over the objections of the Red Cross and other health officials, the United States continues to base its blood donation policies on fear and prejudice rather than science.

The Health and Human Services Advisory Committee on Blood Safety and Availability has voted 9-6 to keep a lifelong ban on any man who has had even one sexual encounter with anther man in the past thirty-three years. Cuz their skurrred of the gay.

There is no medical reason for the ban as it is. All of the blood agencies favor changing the ban. Most other industrial nations do not have a life time ban.

But none of that matters. Because the committee members were not voting based on science, experience or logic.

increasingly accurate tests have been developed to detect HIV in donor blood. The first tests that became available spot antibodies that the immune system produces when confronted by HIV. It usually takes two to eight weeks, but sometimes longer, for the body to make enough antibodies for the tests to detect.

A newer test can find HIV itself in the blood. This test shortens the time between infection with the virus and detection to nine to 11 days.

There is an article in the LA Times about hemophiliacs who oppose loosing the blood donation rules to allow gay men to donate blood in some circumstances. But while the human interest story was touching, what struck me were the following facts:

In the last 16 years, there have been nine known cases of HIV transmission caused by tainted blood.

The last such case was in 2002

In that year there were more than 13.5 million transfusions in the U.S.

There have been over 100,000,000 tranfusions since the last case of tained blood.

Federal health officials announced Friday that they would reexamine a 27-year-old set of restrictions on blood donations by gay men.
…
The FDA “has been actively engaged in reexamining the issue of blood donor deferral for men who have had sex with other men, taking into account the current body of scientific information, and we are considering the possibility of pursuing alternative strategies that maintain blood safety,” the agency said in a statement.

The issue will be examined by the Department of Health and Human Services’ blood safety committee in June, according to the statement.

This commentary is the opinion of the author and does not necessarily reflect that of other authors at Box Turtle Bulletin.

Timothy Kincaid

March 8th, 2010

In 1983, the FDA established a policy requiring that blood banks not accept donations from any male who had engaged in sex with any other man at any point since 1977. This was implemented so as to attempt to eliminate blood which was potentially infected with the HIV virus from the pool, and it made sense at that time.

It wasn’t until 1983 that the HIV virus was identified, and a method of testing for the virus wasn’t established for another two years.

AABB, ABC and ARC believe that the current lifetime deferral for men who have had sex with other men is medically and scientifically unwarranted and recommend that deferral criteria be modified and made comparable with criteria for other groups at increased risk for sexual transmission of transfusion-transmitted infections. Presenting blood donors judged to be at risk of exposure via heterosexual routes are deferred for one year while men who have had sex with another man even once since 1977 are permanently deferred.

Current duplicate testing using NAT and serologic methods allow detection of HIV- infected donors between 10 and 21 days after exposure. Beyond this window period, there is no valid scientific reason to differentiate between individuals infected a few months or many years previously. The FDA-sanctioned Uniform Donor History Questionnaire was developed recognizing the importance of stimulating recall of recent events to maximize the identification of donors at risk for incident, that is, recent, infections. From the perspective of eliciting an appropriate risk history for exposure to HIV and other sexually transmitted infections, the critical period is the three weeks immediately preceding donation since false negative NAT and serology reflect these window-period infections, and the length of these window periods provide the scientific basis for the deferral periods imposed for at risk sexual behaviors.

The FDA refused.

They argue that as gay men have a higher concentration of HIV infection than some other demographics, this justifies a blanket ban on all donations by all gay men.

Men who have had sex with men since 1977 have an HIV prevalence (the total number of cases of a disease that are present in a population at a specific point in time) 60 times higher than the general population, 800 times higher than first time blood donors and 8000 times higher than repeat blood donors (American Red Cross). Even taking into account that 75% of HIV infected men who have sex with men already know they are HIV positive and would be unlikely to donate blood, the HIV prevalence in potential donors with history of male sex with males is 200 times higher than first time blood donors and 2000 times higher than repeat blood donors.

This week, Senator John Kerry, along with several other Senators, sent a letter to the FDA requesting that they reconsider their rules.

“Not a single piece of scientific evidence supports the ban,” the Democratic senator said in a statement. “A law that was once considered medically justified is today simply outdated and needs to end, just as last year we ended the travel ban against those with HIV.”

I doubt that this will be effective. If the FDA refuses to listen to those who know the very most about donation, testing, infection, and the blood supply, why would they listen to John Kerry?

But Kerry’s action does allow us as a nation to re-question why the ban is in place. Is it a matter of heath science or a matter of mistrusting (or disliking) gay men?

The FDA argues that any increased risk of tainting the supply is unacceptable. And that allowing gay men to contribute would unquestionably increase that risk.

But is that true? Does the ban effectively increase the safety of our blood supply? Or does it actually do harm?

To answer these questions, I think we need to look closer at the ban and how it functions.

1. The ban is only as effective as it is perceived to be reasonable. Remember, the ban is voluntary; by that, I mean that the only thing which stops donation is a questionnaire and the donor’s decision to answer honestly. If a gay man is determined to donate, he will only be persuaded not to donate if he believes that the criteria of exclusion is based on reason and not on bias.

2. We must assume that only a psychopath would choose to purposefully donate HIV infected blood. And no questionnaire is going to stop a psychopath. Therefore, this purpose of the questions is to eliminate those who are unknowingly infected.

But who donates blood? According to the Red Cross, only 3 out of 100 of Americans donate. And this 3% is not representative of the population as a whole.

Yes, blood donors come from all races, ages, political affiliations, and economic situations. But they have one thing in common, they are motivated by altruism or a belief that it is in the common good that they donate. They donate because it is the “right thing to do”.

And let’s be practical here for a moment. The type of person who donates blood is not generally the type of person who is irresponsible. If you are a ‘give blood’ type of gay man, you are probably also a ‘get tested’ type of gay man.

So the only unaware HIV-positive infected gay men who are likely to be prevented from donating are those who have good reason to believe (falsely) that they are HIV-negative. That’s not a very big demographic.

3. The FDA does not exclude other demographics who are infected at higher rates than the population at large. For example, over half of all new HIV infections detected in 2007 were in African Americans. While many of those infected are also MSM (men who have sex with men, a term used by the infectious disease community), many are heterosexual. Over 60% of women with AIDS are black. (AVERT)

The estimated lifetime risk of becoming infected with HIV is 1 in 16 for black males, and 1 in 30 for black females, a far higher risk than for white males (1 in 104) and white females (1 in 588).

There are many reasons for this (and for godsake let’s allocate more resources to stemming this trend) and I’m not trying to make comparisons or demonize anyone. But it does demonstrate that the FDA’s banning policies seem inconsistent.

The screening does seek to eliminate those women who might have had sex with a MSM or intravenous drug user in the recent past, but it does not issue a blanket ban based on race (nor should it). However, the “ever had sex at any time in your friggin’ life” definition effectively serves as a ban based on orientation.

So while the FDA does not say that the President of the United States is banned from blood donation based on his ethnicity, it does prohibit donation by Rep. Barney Frank.

4. Not all gay men are equally at risk. Homosexual activity does not create HIV. It is a virus, not a consequence of specific sexual acts. Only about 12% of gay men are infected with the HIV virus.

Yet the FDA treats my friends, a couple in their 40’s who met in high school and have been together ever since, the same as it does some gay man who is single and has an active and diverse sex life. Ironically (and amusingly) it considers ex-gays like Alan Chambers to be no less of a risk than the man whose fetish is to be the recipient in unprotected anal sex.

The FDA clumps gay men into a single demographic and assumes that all gay men are at a higher risk than all heterosexuals.

While statistics indicate a rising infection rate among young heterosexual women, their overall rate of HIV infection remains much lower than in men who have sex with other men.

But clumping in this manner is a foolish and rash policy. Contamination is more likely to come from a young single heterosexual woman who relies on the pill than it is from a gay man in a committed relationship who uses condoms regularly.

5. While the ban on gay men donating does not – in my opinion, as discussed in the points above – serve to diminish much risk of contaminating the blood supply with the HIV virus, it is quite effective at something else: labeling all gay people as dirty and diseased.

This universal ban says, in effect, that all gay men are suspect, a cause of concern, human rats carrying contagion. It feeds the myth that gay equals AIDS and lends credence to the anti-gay activists who market in fear and animus.

But is lifting the ban the answer?

I would argue that a full lifting of the ban is not a wise decision. That would increase – at least in some tiny measure – the risk of taint to the blood pool. Rather, I would advise to change the policy in a way that not only increases the blood supply and to reduces stigma but which also could serve an additional medical function.

Obviously the screening questions need to eliminate the risk of undetected recent infections. But such risks should be based on actual behavior based risk, not on stereotyping of communities. This may even serve to reduce the risk of accidental taint from gay men who ignore the current policy as being nothing more than bias.

Science-based periods of either long-term monogamy or sexual abstinence would likely be respected as reasonable and appropriate. Few gay men would argue that every gay man, regardless of sexual history or responsibility, should donate blood.

And revising the rules for donation to match the requests of the Red Cross would certainly be better than the current policy. But I recommend a different approach.

I recommend that all persons who have any risk of HIV transmission – be they gay men, single heterosexuals, or anyone else who could be at risk – be required to take an HIV test as a step in the donation process. Those persons who tested negative and who had no sexual contact for the previous six months (or whatever restrictions are reasonable) could be treated as acceptable donors. The oral swab tests are non-intrusive, give a response in 20 minutes, and are more than 99% accurate.

The current controls over the blood supply do an amazing job at detecting and removing infected blood. But implementing a screening method that is based on measurability rather than voluntary deferral would effectively eliminate unknown carriers, gay or otherwise.

And it would also reach a population of potentially at-risk citizens who might otherwise go undetected.

The single largest contributor to the spread of HIV is unknown infection. Granted, as I discussed above, those gay men who are most likely to donate blood are also among those most likely to be tested regularly. But HIV testing at a blood donation site could provide access and a safe friendly environment for non-gay people who might be a bit intimidated or uncomfortable asking their doctor or going to the testing center in the gay part of town.

We told you yesterday of Doctor Brenton Wylie, an expert witness for the Red Cross appearing before the Tasmanian Anti-Discrimination Tribunal to explain why gay men are excluded from giving blood. Dr. Wylie presented some statistics that are mathmatically ludicrous.

Now the Red Cross runs the risk of sounding like a bunch of extremist homophobes with little to no connection to reality.

US professor Dr Paul Holland, a former blood source executive testifying for the Red Cross, claimed even digital penetration of the nose or ear would justify the lifetime ban his country imposes on gay men.

“That would usually be sufficient to exchange fluid and qualify as sex,” Dr Holland told the Tribunal. When asked if that included gay men who had done nothing more than kissing, Holland replied, “Yes, sir, because they increase their chance of transmitting an infection such as HIV.”

Really, Dr. Holland?

In theory prolonged kissing of a rough nature could result in bleeding which could in the right circumstances enter the bloodstream of an uninfected person through a cut in the mouth. To date I believe the CDC lists a grand total of one person (a heterosexual woman) for whom this may have been a possible cause of transmission.

But is there a sane person out there who thinks that kissing is a significant risk for HIV transmission? And the logic behind excluding gay men who kiss from blood donation based on the example of this heterosexual woman evades me.

The Red Cross’ lawyer also took a page out of the anti-gay Christian lobby’s strategy stating gay male monogamy was a myth.

The Tribunal has heard a flurry of statistics from the Red Cross based on a New Zealand focus group of 11 couples that appeared to show gay men have 10 times as many partners as heterosexual men.

In a manner worthy of Paul Cameron, the focus group that Holland quoted explicitly excluded men who practice safe sex in monogamous relationships.

It seems that in an effort to shore up their policy, the Red Cross in Australia has signed on a bunch of anti-gay loons unafraid to make the most bizarre and irrational of claims. And that is unfortunate.

All of us rely on the safety of the blood bank in our country. And if there are legitimate reasons based on sound science for excluding all gay men, they should be given careful consideration and not be tainted by extremist anti-gay nonsense.

And if there are other areas of concern that need immediate attention which are being ignored or given less emphasis – such as the growing epidemic in the Asia Pacific region or the highly increased mortality resulting from old blood – then the health of all Australians or visitors is being threatened just to accomodate the outmoded homophobic presumptions and attitudes of those in charge.

When Michael Cain was denied the ability to donate blood to Australia’s supply because he had been in a same-sex relationship, he decided to sue. He is claiming that standards should rely upon whether the person engages in unsafe sex practices rather than on their orientation.

Doctor Brenton Wiley told Hobart’s anti-discrimination tribunal today that the incidence of HIV infection among gay men is more than 1,000 times higher than regular donors.

Well, it would seem that Dr. Wiley is either very poorly informed about the subject for which he is an expert witness or he cannot do simple math.

According to Avert, there were about 15,670 people living with HIV in Australia at the end of 2006, or about 0.078% of the population. If HIV infection were 1,000 higher it would mean that 79% of gay men in Australia have HIV.

Really, Dr. Wiley?

Well we also know that as of 2006 there were roughly 10,650 gay men living with HIV. If Dr. Wiley’s claims were true, Australia would have a total gay male population of 13,500.

Anyone who has seen the hundreds of thousands of revelers at Sydney’s Gay Pride parade alone would have to scoff at Dr. Wiley’s magical math.

In 1983 the FDA wisely decided that gay men should not donate blood to the country’s blood banks. HIV had not been identified and no tests were available to identify its presence.

Things have changed since 1983. Now you can take a saliva-swab test and find out your HIV status within 20 minutes. And it is increasingly likely that gay men regularly test and are aware of their seroimmunity status.

Also, the face of HIV/AIDS has changed. In 2005, only half of reported HIV transmissions were related to sex between men. And currently the greatest contributing factor to HIV transmission and to knowledge of HIV status is race.

Taking these changes into consideration, those responsible for our blood supply called gay ban “medically and scientifically unwarranted” and requested that the FDA rethink their requirements.

In March 2006, the Red Cross, the international blood association AABB and America’s Blood Centers proposed replacing the lifetime ban with a one-year deferral following male-to-male sexual contact. New and improved tests, which can detect HIV-positive donors within just 10 to 21 days of infection, make the lifetime ban unnecessary, the blood groups told the FDA.

The FDA said “no” because “men who have sex with other men have the highest risk of transfusion-tramsmitted diseases like HIV and hepatitis.”

I would like to believe that decisions made in Federal agencies are based on fact and science rather than because of appointments predicated on ideology and political loyalties and alliances. I would like to think that this decision was made because the FDA put principle and protection first and not the religious-based agenda of the administration’s partisan allies.

Given what the medical community knows today, do you think the FDA is being overly cautious in upholding its 1983 ban on gay men?

“I support a less stringent deferral,” Katz said. “I think deferring blood donation to six months or one year after male-to-male sexual contact is reasonable and would not have a negative impact on the current safety of our blood supply. I understand their thought process. But the other issue is fairness. Not all men who have sex with men are at high risk for HIV. I’m not violently angry about it, but I think they could have dealt with the concern a little differently.”

Dr. Katz is more generous than I. He can see faulty thinking, while I see policy that eliminates healthy blood contributions during a time when the need is increasing. And while I too am not violently angry, I am fully disgusted at the politicians who place their biases, stereotypes, religious alliances, and personal loyalties over what is best for our nation.

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